Sensor for acquiring physiological signals

ABSTRACT

A device for acquiring and collecting physiological signals is disclosed. In at least one embodiment, the device provides an at least one sensor having a conductive layer comprising a conductive fabric of interlaced conductive and non-conductive fibers and a plurality of orifices throughout the conductive fabric, wherein the plurality of orifices are filled with a silicone rubber, and wherein the silicone rubber is attached to the conductive fabric without the use of an adhesive. An electrical connector is connected to the conductive layer, the electrical connector providing a separable interface between the conductive layer and an electronic instrument. The device further provides an electronic instrument for receiving and collecting signals acquired from the at least one sensor.

RELATED APPLICATIONS

This is a continuation application and so claims the benefit pursuant to35 U.S.C. § 120 of a prior filed and co-pending U.S. non-provisionalapplication Ser. No. 15/461,275, filed on Mar. 16, 2017, which itself isa continuation of U.S. non-provisional application Ser. No. 13/988,007,filed on May 16, 2013 (now U.S. Pat. No. 9,629,584, which issued on Apr.25, 2017), which is a 35 U.S.C. § 371 U.S. national stage entry ofinternational application serial number PCT/EP2011/070296, filed on Nov.16, 2011, which claims priority to both U.S. provisional applicationSer. No. 61/427,864, filed on Dec. 29, 2010, and EP application serialnumber 10191590.8, filed on Nov. 17, 2010. The contents of theaforementioned applications are incorporated by reference herein.

BACKGROUND

The present invention relates to sensors for acquiring physiologicalsignals, devices comprising these sensors, as well as garmentscomprising these devices.

Applicant(s) hereby incorporate herein by reference any and all patentsand published patent applications cited or referred to in thisapplication.

By way of background, sensors comprising electrodes are used extensivelyin the assessment of clinical condition, for example in the monitoringof cardiac condition. The electrodes are placed in contact with the skinof the human body and the electrical physiological signals which resultare examined.

Nevertheless, stability, noise and sensibility of the signals can beaffected by different reasons; motion and long term acquisition of thesignal are two of the most significant.

One of the physiological signals most affected by the different types ofnoise, as electrode contact noise or movement noise is theElectrocardiogram (ECG) signals. ECG is a long term analysis and toacquire a good signal it is crucial that the signal's parameters arestables.

As the ECG is a long term analysis, a garment that include an ECG sensoris essential to monitor this type of physiological signals in the dailylive.

It is known in the state of the art, garments with sensors integrated inthe textile. The sensor to be integrated in a garment must be a systemminimal invasive, flexible, conformable to the human body including inmovement, comfortable and resistant to repeated washing.

The current state of the art in textile sensors presents differentdrawbacks: i) Low adhesion to skin. Each relative motion between skinand electrode causes alterations in the signal. This limitation is verysignificant in the context of use of electrodes during physicalactivity. ii) Signal alterations. These are produced by the movement ofthe conductive fibers and the presence of wrinkles. iii) Decrease of thesignal quality with time. In some sensors to ensure the skin contact,liquids such as water or grease can be used between the contact layerand the skin. In dry environments it is not possible to remain the skinmoisture level constant and the electric conductivity of the contactlayer decreases.

The patent application EP1361819, which applicant was Polar Electro,OY., describes a sensor which comprises a contact layer includingconductive fibers, and a moisture layer for retaining moisture on thetop of the contact layer. The moisture layer retains secretory productsfrom the skin, such as moisture and electrolytes. This enhances thecontact between the skin and the contact layer and increases theelectric conductivity of the contact layer, but the comfortable of thegarment is minor as the humidity in the skin and inside the garment isincreased.

The patent application EP2072009 describes a garment comprising at leastone electrocardiogram sensor integrated into the garment comprising anelectrode on the inside of the garment and arranged to contact a user'sskin; and a resilient compressible filler provided between the garmentand the electrode. The resilient compressible filler holds the electrodein place when the garment moves. The resilient compressible filler couldbe uncomfortable for the user.

The patent application US20100234715 describes a garment for measuringphysiological signals. The garment including an electrode sensor coupledto an inner surface of a garment to make contact with the skin fordetecting physiological signals; a signal connection line connected tothe electrode sensor, a snap and a measurement unit. The electrodesensor unit is coupled to a desired portion of a garment using acoupling adhesive member which is may have opened frame shape forattaching edges of the electrode sensor to the garment. An anti slippingadhesive tape (member) may be formed along the border of the electrodesensor and the coupling adhesive member.

Thus, from what is known in the art, it is derived that the developmentof a sensor and a garment comprising the sensor which allow recordingphysiological signals, especially in movement, with improved adhesionproperties but avoiding adhesive elements which produce skin irritationsand with flexibility properties, is still of great interest.

Aspects of the present invention fulfill these needs and provide furtherrelated advantages as described in the following summary.

SUMMARY

Aspects of the present invention teach certain benefits in constructionand use which give rise to the exemplary advantages described below.

The present invention solves the problems described above by providing adevice for acquiring and collecting physiological signals. In at leastone embodiment, the device provides an at least one sensor having aconductive layer comprising a conductive fabric of interlaced conductiveand non-conductive fibers and a plurality of orifices throughout theconductive fabric, wherein the plurality of orifices are filled with asilicone rubber, and wherein the silicone rubber is attached to theconductive fabric without the use of an adhesive. An electricalconnector is connected to the conductive layer, the electrical connectorproviding a separable interface between the conductive layer and anelectronic instrument. The device further provides an electronicinstrument for receiving and collecting signals acquired from the atleast one sensor.

Other features and advantages of aspects of the present invention willbecome apparent from the following more detailed description, taken inconjunction with the accompanying drawings, which illustrate, by way ofexample, the principles of aspects of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate aspects of the present invention.In such drawings:

FIG. 1A illustrates an exemplary orifice pattern in an exemplaryelectrode, in accordance with at least one embodiment;

FIG. 1B illustrates an exemplary groove pattern in the electrode, inaccordance with at least one embodiment;

FIG. 1C illustrates an exemplary orifice pattern in the electrode with asilicone rubber pattern on the surface of the electrode, in accordancewith at least one embodiment;

FIG. 1D illustrates a front view of a conductive fabric with theorifices filled with silicone rubber, in accordance with at least oneembodiment;

FIG. 2 illustrates an exploited perspective view of an embodiment of asensor, in accordance with at least one embodiment;

FIG. 3A illustrates a cross-section of an embodiment of a sensor, inaccordance with at least one embodiment;

FIG. 3B illustrates a cross-section of an embodiment of a sensor, inaccordance with at least one embodiment;

FIG. 4 illustrates an elevation view of the garment, in accordance withat least one embodiment;

FIG. 5 illustrates a cross-section elevation view of a connectionbetween an embodiment of a sensor and an electronic instrument, inaccordance with at least one embodiment;

FIG. 6 shows the Amplitude RS (A(v)) in resting (A), stand (B),stand/sit (C), bend (D), arms (E), walk (F), and all the activities,resting, stand stand/sit, bend arms and walk (G) for Zephyr™ HxM strap(I), Polar TEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirtof the invention (IV), in accordance with at least one embodiment;

FIG. 7 shows RMS/Amplitude RS in resting (A), stand (B), stand/sit (C),bend (D), arms (E), walk (F), and all the activities, resting, standstand/sit, bend arms and walk (G) for Zephyr™ HxM strap (I), Polar TEAM²strap (II), Numetrex® Cardio-Shirt (III) and the shirt of the invention(IV), in accordance with at least one embodiment;

FIG. 8 shows the percentage of good QRS complex in resting and dailyactivity for Zephyr strap (I), Polar strap (II), Numetrex shirt (III)and the shirt of the invention (IV), in accordance with at least oneembodiment;

FIG. 9 shows the autocorrelation value for Zephyr™ HxM strap (I), PolarTEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirt of theinvention (IV), in walking (F), arms(E), stand (B), bend (D), stand/sit(C) and resting (A), in accordance with at least one embodiment;

FIG. 10 shows the Amplitude RS (A(v)) in mid-speed (H), fast-speed (I),torso-move (J), racket (K), jump (L), and all the activities, mid-speed,fast-speed, torso move, racket and jump (M) for Zephyr™ HxM strap (I),Polar TEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirt ofthe invention (IV), in accordance with at least one embodiment;

FIG. 11 shows RMS/Amplitude RS in mid-speed (H), fast-speed (I),torso-move (J), racket (K), jump (L), and all the activities, mid-speed,fast-speed, torso move, racket and jump (M) for Zephyr strap (I), Polarstrap (II), Numetrex shirt (III) and the shirt of the invention (IV), inaccordance with at least one embodiment;

FIG. 12 shows the percentage of good QRS complex in strong physicalactivity for Zephyr strap (I), Polar strap (II), Numetrex shirt (III)and the shirt of the invention (IV), in accordance with at least oneembodiment;

FIG. 13 shows the autocorrelation value Zephyr™ HxM strap (I), PolarTEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirt of theinvention (IV) in mid-speed (H), fast-speed (I), torso-move (J), racket(K) and jump (L), in accordance with at least one embodiment; and

FIG. 14 shows RMS/Amplitude RS in mid-speed (H), fast-speed (I),torso-move (J), racket (K), jump (L), and all the activities, mid-speed,fast-speed, torso move, racket and jump (M) for the shirt of theinvention (IV), black column and the shirt of the invention withoutsilicone rubber (V), white column, in accordance with at least oneembodiment.

The above described drawing figures illustrate aspects of the inventionin at least one of its exemplary embodiments, which are further definedin detail in the following description. Features, elements, and aspectsof the invention that are referenced by the same numerals in differentfigures represent the same, equivalent, or similar features, elements,or aspects, in accordance with one or more embodiments.

DETAILED DESCRIPTION

A target of the present invention is the monitoring of the user inphysical activity on a continuous and non-invasive mode, without addingany restrictions. Thus, the sensor 1 of the present invention allowsmeasuring the electrical physiological signals during physical activity.

As mentioned above, a first aspect of the invention relates to a sensor1 to be placed in contact with the skin 12 of an user for acquiringphysiological signals which comprises: a) a conductive layer 2comprising at least conductive fibers to be placed in contact with theskin 12 for receiving physiological signals; b) an electrical connector5 connected to the conductive layer; characterized in that theconductive layer comprises a plurality of orifices 6 filled with ansilicone rubber throughout the conductive area.

The term “sensor” as used herein, refers to a component that receivesphysiological signals and transforms them into electrical signals.

The term “electrode” as used herein, refers to the area of theconductive layer that is in contact with the skin and wherein thephysiological signal is received.

The term “track” as used herein, refers to the area of the conductivelayer where the electrical connector is located. The track transmittersthe physiological signal from the electrode area to the electricalconnector.

The term “electrical connector” as used herein, refers to anelectromechanical device which provides a separable interface betweentwo electronic subsystems, sensor and electronic instrument, without anunacceptable effect on signal integrity.

The term “anti-slip material” as used herein, refers to a material witha material/skin friction coefficient of al least 0.5. In a preferredembodiment, the anti-slip material is silicone rubber.

The term “hot melt adhesive” as used herein, refers to a thermoplastic,non-structural adhesive that flows when heated and hardens andstrengthens as it cools.

The term “screen printing”, as commonly known in the art, refers to aprocess made using a stencil in which image or design is print on a veryfine mesh screen and the printable material is squeegeed onto theprinting surface through the area of the screen that is not covered bythe stencil.

Traditionally the process was called screen printing or silkscreenprinting because silk was used in the process. Thus, “silk printing”,“screen printing” and “silk screen printing” are synonymous among them.

In an embodiment of the first aspect of the invention, the conductivelayer 2 is made of conductive material, selected from conductive fabric.

In another embodiment of the first aspect of the invention, it isprovided a sensor 1 adapted to be integrated in a garment 7 so as to beplaced in contact with skin 12 of a user during the use of the garment7, wherein said sensor 1 comprises a conductive layer 2 to be placed incontact with the skin 12 for receiving physiological signals comprisingat least: an electrode 3; a track 4; and an electrical connector 5connected with the track 4; wherein the electrode 3 of the conductivelayer 2 comprises a plurality of orifices 6 or grooves 11 in apredefined pattern filled with an anti-slip material. Preferably theelectrode 3 of the conductive layer 2 comprises a plurality of orifices.

According to an embodiment of the invention the electrode 3 and thetrack 4 are made of the same or different material. In a preferredembodiment of the first aspect of the invention the electrode 3 andtrack 4 independently from each other is a conductive fabric comprisingconductive fibers and non conductive fibers.

In a preferred embodiment of the first aspect of the invention, theelectrode 3 and the track 4 refer to a conductive fabric made ofconductive fibers.

In other preferred embodiment of the first aspect of the invention, theelectrode 3 and track 4 refer to a conductive fabric made of conductivefibers and non conductive fibers.

Preferably, the conductive fibers are made of silver coated nylon (suchas Xstatic® yarns from Laird Sauquoit Industries) and the non conductivefibers are made of nylon.

Non limiting examples of conductive fibers are fiber made of silver,copper, nickel, stainless steel, gold, non conductive fibers coated witha conductive material or mixtures thereof. Non limiting examples ofcoating conductive materials are silver, cooper, nickel, stainlessstell, gold and silicone rubber loaded with carbon or silver powder.

Non limiting examples of non conductive fibers are wool, silk, cotton,flax, jute, acrylic fiber, polyamide polyester, nylon and/or withelastic yarns (such as LYCRA® branded spandex from Invista™ S.a.r.l).

The conductive layer with conductive and non conductive fibers are notonly more flexible than the conductive layer formed from metal fibersonly, but also tend to be lighter and more resistant to oxidation.Because the fibers can be knit tightly, the electrical conductivity ofthe fabric can be maintained despite a partial loss of the conductivecoating on particular threads, whereas in metal fiber conductivefabrics, the fabric may lose operability after a break in one of thefibers, particularly if the fibers are spaced far apart. The amount ofmetal in the fabric is a compromise between the demand to increase theconductivity and the necessity to improve the touch sensation of thecloth.

As a result of the interlacing of fibers, the fabric shows a pluralityof orifices 6 among fibers. According to an embodiment of the invention,the electrode is drilled or grooved in order to make additional orifices6 or grooves 11 or to make larger the orifices 6 of the electrode in apredefined pattern.

The plurality of orifices 6 or grooves 11 present different pattern ascircular, sinusoidal pattern, straight lines pattern, hexagon patternand other different geometric shapes pattern, or a combination thereof.The plurality of orifices 6 form a matrix random or organized.

The presence of such orifices 6 or grooves 11 in the conductive layerresults in an improvement of the elasticity of the layer. By filling theconductive layer orifices 6 or grooves 11 with the silicone rubber it isreached an improvement in the adherence of the sensor to the skin and atthe same time it is improved the signal measured, because the noise ofthe signal is reduced.

The silicone rubber before the process of cured is in a liquid state.When the silicone is in the liquid state is printing in the fabric. Thismeans that the union silicone-fabric is an union without an adhesive.The electrically conductive layer described in the invention isintegrated into the fabric. The silicone in the liquid state when isprinting in the fabric is capable to penetrate in the orifices of thefabric, anchoring with the structure of the conductive layer.

When the orifices 6 or grooves 11 are filled, the silicone rubberpresent a flat or relief profile. In a preferred embodiment the siliconerubber shows a relief profile.

In a preferred embodiment the silicone rubber is a silicone rubber withmolecular weight comprised between 400 g/mol and 600 g/mol.

As described above the sensor 1 of the invention is to be placed incontact with the skin 12. In a preferred embodiment the proportion ofconductive layer 2 to be in contact with the skin is comprised between50% and 80% of the conductive layer and the proportion of the siliconerubber to be in contact with the skin 12 is comprised between 20% and50% in respect to the total conductive layer 2. In a most preferredembodiment the proportion of conductive layer 2 to be in contact withthe skin 12 is comprised between 60% and 70% of the conductive layer 2and the proportion of the silicone rubber to be in contact with the skin12 is comprised between 30% and 40% in respect to the total conductivelayer 2.

In a preferred embodiment the track 4 and the electric connector 5 arecovered with an insulating material 8.

In sensor on contact with the skin of the user the electrode/skinresistance is one of the elements to determine the noise of the signals.In a preferred embodiment the resistance of the electrode 3 is comprisedbetween 1Ω and 10Ω. In a more preferred embodiment the resistance of thetrack 4 is comprised between 1Ω and 50 kΩ.

A second aspect of the present invention is a device comprising at leastone sensor 1 of the invention and an electronic instrument 14 forreceiving and collecting and/or storing and/or processing, and/ortransmitting data from said sensor.

Using the sensor of the invention, the physiological signals detectedcan be at least one of the following data: cardiac pulse, respiratoryfrequency, electrodermal response (EDR), measures electrical skinconductivity, electrocardiography (ECG), electromyography (EMG). Thesesignals refer to electrical signals produced in the body. Preferably thedata are ECG data.

A third aspect of the present invention is a garment 7 which integratesthe device of the invention.

In an embodiment of the third aspect, the garment 7 is designed forapplying a pressure equal or higher than 2 KPa. In another embodimentthe garment 7 comprises two layers, an inner and an outer layer 13, andthe outer layer 13 compresses the sensor to the body with at least 2KPa. In a most preferred embodiment the outer layer 13 comprises asystem to regulate the pressure.

Preferably, the inner layer has low elasticity and the outer layer 13has high elasticity. The inner layer is comprised of a blend ofsynthetic fiber and spandex, wherein the synthetic fiber comprises 85%to 90% by weight of the composite elastic material and most preferably87% to 89%, and wherein the spandex comprises 10% to 15% by weight ofthe composite elastic material, and most preferably 11% to 13%. Theouter layer 13 is comprised of a blend of synthetic fiber and spandex,wherein the synthetic fiber comprises 92% to 97% by weight of thecomposite elastic material and most preferably 94% to 96%, and whereinthe spandex comprises 3% to 8% by weight of the composite elasticmaterial, and most preferably 4% to 6%. The outer layer 13 compressesthe sensor to the skin, and the stability and fixation of the sensor 1are improved.

In an embodiment of the third aspect, the track 4 of the conductivelayer 2 of the sensor 1 is placed between the inner and the outer layer13 of the garment, and the electrode 3 is over the inner layer of thegarment, the electrode 3 being able to be in contact with the skin 12 ofthe user of the garment 7.

The sensor 1 can be prepared by a process comprising the steps of:

-   a) die cutting a conductive layer of conductive fabric;-   b) adding a hot melt adhesive on one surface of the conductive    layer;-   c) screen printing with an anti-slip silicone rubber on the orifices    6 or grooves 11 of the electrode 3, at a temperature comprise    between 10-30° C.; and-   d) curing the silicone, preferably for up two minutes at a    temperature comprised between 130-190° C.

The process can further comprise the step of screen printing with ansilicone rubber loaded with an conductive material to form the track 4.

A particular embodiment of the invention orifices 6 pattern of theelectrode 3 is illustrated in FIG. 1A. FIG. 1B shows a preferred groovespattern 11 of the electrode 3. FIG. 1C illustrates an electrode 3 withthe orifices 6 filled with silicone rubber, wherein the electrode 3shows the silicone rubber in a predefined pattern on their surface in arelief profile. Therefore, the silicone rubber anchorages with thefabric of the electrode, through the filling of the orifices.

FIG. 2 shows an exploited perspective view of a sensor 1 wherein theconductive layer 2 comprises the electrode 3 and track 4. As mentionedabove, the electrode 3 present circular orifices 6 filled with siliconerubber. The electrical connector 5 is in contact with the track 4 of theconductive layer 2 and the track 4 can be covered with an insulatingmaterial 8. The electrical connector 5 comprises a first and secondportion, wherein the first portion comprise a female-type clip portion 9and the connector second portion may comprise a male-type stud portion10, which portions mate with each other.

Alternatively, the connector first portion may comprise a male-type studportion and the connector second portion may comprise a female-type clipportion, which portions mate with each other. Typically, when the sensor1 is integrated in a garment 7, male a female portions of the electricalconnector are placed on the opposite face of the garment each other.Thus, the male or female portion which is placed in the inner face,which will be in contact with the skin 12 of the user, is covered withan insulating material 8, which also covers the track 4 of theconductive layer 2.

FIG. 3A illustrates a cross-section of the sensor 1 of the invention.The cross-section of the sensor 1 shows the electrode area 3 and thecircular orifices 6 filled with silicone rubber. The track 4 is made ofthe same material than the electrode 3. The track and the electrode aremade of conductive fabric. The sensor of the invention is in contactwith the skin 12.

FIG. 3B illustrates a cross-section of an embodiment of a sensor 1according to the present invention. In this embodiment the electrode ismade of conductive fabric and the track 4 is made of silicone rubberloaded with a conductive material.

FIG. 4 illustrates an elevation view of the garment 7 with two sensor 1placed near the chest area. The outer layer 13 of the garment 7 pressesthe sensor with at least 2 KPa.

FIG. 5 illustrates a cross-section elevation view of a connectionbetween an embodiment of a sensor 1 according to the present inventionand an electronic instrument 14. The sensor 1 is connected to theelectronical connector 5 using a female-type clip portion 9 and amale-type stud portion 10.

Throughout the description and claims the word “comprise” and variationsof the word, are not intended to exclude other technical features,additives, components, or steps. Additional objects, advantages andfeatures of the invention will become apparent to those skilled in theart upon examination of the description or may be learned by practice ofthe invention. The following examples and drawings are provided by wayof illustration, and they are not intended to be limiting of the presentinvention. Reference signs related to drawings and placed in parenthesesin a claim, are solely for attempting to increase the intelligibility ofthe claim, and shall not be construed as limiting the scope of theclaim. Furthermore, the present invention covers all possiblecombinations of particular and preferred embodiments described herein.

Comparative Example Between a Garment with the Sensor of the Inventionand Other Garments with Fabric Sensor Technology

Zephyr™ HxM (made by Zephyr Technology Corporation) (I), Polar TEAM²(made by Polar Electro, OY.) (II), Numetrex® Cardio-Shirt (made byTextronics, Inc.) (Ill) and the shirt of the invention (IV), wherein thetrack and the electrode are made of conductive fabric and the electrodearea has the orifices filled with silicone rubber, were tried. TheNumetrex® Cardio-Shirt is a shirt with textile electrodes knitted intothe fabric. The Zephyr™HxM strap and Polar TEAM² strap are straps withtextile electrodes. The Zephyr™ HxM strap includes an electrode and aresilient compressible filler provided between the garment and theelectrode such that, in use, the electrode is held substantially inplace against the skin when the garment moves relative to the user'sskin. The Polar TEAM² strap includes a contact layer includingconductive fibres, and a moisture layer for retaining moisture on top ofthe contact layer.

The test protocol in which performed activities were divided indifferent levels of physical exigency: resting, daily activity andstrong physical activity.

The subject was monitored with a device compatible with all the strapsand shirts tested.

The exercises of the protocol were defined as following:

Resting (A): the subject remained lay down in a table for 30 seconds.

Daily activity is defined by:

Stand (B): the subject stood on his feet still for 20 seconds withoutmoving.

Sit down/stand up (C): the subject sat down and stood up of a chair 4times, remaining 3 seconds in each state.

Bend down (D): the subject bent down 3 times, always in the same way(without flexing his knees).

Arm movement (E): the subject moved his arms in different directions(straight, horizontal and vertical) 3 times each.

Walk (F): The subject walked at a approximate speed of 3 km/h for 20seconds.

Strong Physical Activity (H) is Defined by

Moderate-speed Running (I): the subject ran at a speed of 6 km/h during20 seconds.

Fast-speed Running (J): the subject sped up his pace until he reached 10km/h, then he stayed running at this speed during 15 seconds.

Strong arm movement (racket move) (K): the subject moved his armstrongly simulating hitting a ball with a racket (with both arms), doingthis movement 5 times.

Torso turning (L): keeping the feet in the same position, the subjectturned his torso in both directions, 5 times each.

Jumping (M): the subject jumped high, he will run two or three metersand then he will jumped again. He repeated this movement 5 times.

Strong physical activity, were more physical demanding than the dailyactivity. It is also important to underline that the subject sweatedduring these exercises, so all of the results were in these conditions.

All the exercises done in the resting and daily activities were with thestrap or shirt put directly onto the subject (no sweat) and all thestrong physical activity was done with the strap or shirt worn by thesubject when he was already sweat.

When the different electrocardiographic signals were obtained with eachshirt or strap were performed a sort of measures over these signals toevaluate the different technologies.

The measures performed on the signals were (for each exercise of eachactivity):

Visual Measures

This measure is a direct recognition, just by watching the signal, ofthe quality of the signal acquired in terms of morphology and beatsdetected. This visual recognition is also used to identify what beats(QRS complexes) are recognizable as beats and which of them are toonoisy to be recognized by a cardiologist. A total of 250 beats wereanalyzed for resting and Daily Activity and for Strong PhysicalActivity. A total of 500 beats were analyzed.

Measures Over the Signal

These measures were made on the signal registered in each exercise ofeach activity session. These measures involve manual and automaticanalysis of the recorded signals.

Autocorrelation:

The signal was segmented each 3 seconds with an overlap of 2 secondsbetween blocks and the autocorrelation was done of each block. Thismeasure follows the next formula:

${R_{x}(m)} = {\left( {{1/N} - {❘m❘}} \right){\sum\limits_{n = 0}^{N - 1}{x_{n}x_{n + m}}}}$where x is a signal of N samples. Then it's normalized regarding to thevalue of R_(x) (0). Then we obtain the autocorrelation maximum that it'snot the one in R_(x norm) (0), because it's sure that we have a maximumin this point because the signal is compared with itself without shift.

This index give us a measure of how much does the signal resemble to ashifted itself (starting from the premise that a heartbeat and the nextone are very similar). In this way, values close to 1 show that thesignal is very similar to a shifted copy of itself, so it's clean ofnoise, while low values closet to zero show that the signal is corruptedby noise.

T-P Segment RMS:

The RMS (Root Mean Square) of the T-P segment was calculated in betweenheartbeats (aprox. 20 segments). This measure was done for each exerciseand, averaged, give an estimate of the noise in the signal, particularlyin Resting state, because the T-P segment is isoelectric.

These measures were done manually (to select the beginning and end ofeach segment). In those signals where the T wave was not present(Zephyr™ HxM and Polar TEAM² straps and Numetrex® Cardio-Shirt inResting and Daily Activity), the segment is defined between twoconsecutive heartbeats. This value has to be as low as possible but hasto be contextualized with the QRS amplitude (see the pointRMS/AmplitudeRS).

Maximum T-P Segment:

It measures the maximum peak of noise of the different T-P segments.This value was useful to see if high peaks of noise contaminate oursignal.

Maximum Amplitudes:

The amplitudes of the QRS peaks was measured (R peaks and S peaks, toget RS amplitude) for the beats of each exercise. There was not apreferred value but higher values tend to be better to low ones (lowones are more prone to noise).

RMS/AmplitudeRS:

This factor was calculated with the measures explained in the previouspoints. This index gives us and accurate idea of the noise of the systemin the different exercises. It's normalized regarding to the RSAmplitude because each shirt/strap captures a different amount ofsignals, different amplitudes, so RMS in the T-P segment has to becontextualized to each sensor strap or shirt. For this value, the lowerthe better.

Of all the index and values obtained, the most important ones areRMS/AmplitudeRS and Autocorrelation because both of them are very goodindicators of the noise that contaminate the signals and howrecognizable are the heartbeats in the registered signals.

The results were presented divided in three sections: results forResting and Daily Activity, results for Strong Physical Activity.

Resting and Daily Activity

FIG. 6 shows the amplitude RS (A(v)) in resting (A), stand (B),stand/sit (C), bend (D), arms (E), walk (F), and all the activities,resting, stand stand/sit, bend arms and walk (G) for Zephyr™ HxM strap(I), Polar TEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirtof the invention (IV). The amplitude RS gives an idea of how much signaldoes our system capture, so a high amplitude RS is better. FIG. 6 showsthat the shirt of the invention captures better signal than the othersystems, it works better in dry conditions (this activity sessiondoesn't involves sweating).

FIG. 7 shows RMS/Amplitude RS in resting (A), stand (B), stand/sit (C),bend (D), arms (E), walk (F), and resting and daily activity (resting,stand stand/sit, bend arms and walk) (G) for Zephyr™ HxM strap (I),Polar TEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirt ofthe invention (IV). This data is important because the noise iscontextualized regarding to the AmplitudeRS, and it's a good measure ofthe SNR (Signal-to-Noise Ratio) of the system. The value calculated hereis Noise-to-Signal, so the lower this value is the better. The shirt ofthe invention (IV) show the lowest value.

FIG. 8 shows the percentage good QRS complex in resting and dailyactivity for Zephyr™ HxM strap (I), Polar TEAM² strap (II), Numetrex®Cardio-Shirt (III) and the shirt of the invention (IV). FIG. 8determines how many beats are recognizable as QRS at first sight. Atotal of 250 beats were analyzed for each system, and the results hereare the total of the Resting and Daily Activity Session (not dividedinto exercises). The higher the percentage is the better. The highestvalue it is the value of the shirt of the invention (IV).

FIG. 9 shows the autocorrelation value for Zephyr™ HxM strap (I), PolarTEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirt of theinvention (IV) in walking (F), arms (E), stand (B), bend (D), stand/sit(C) and resting (A). This information is also important because it is agood indicator of the quality, reproducibility and the similitudebetween the heartbeats. The closer this value is to 1, the better. Theshirt of the invention show the closest value to 1.

Strong Physical Activity

FIG. 10 shows the Amplitude RS (A(v)) in mid-speed (H), fast-speed (I),torso-move (J), racket (K), jump (L), and all the activities,(mid-speed, fast-speed, torso move, racket and jump) (M) Zephyr™ HxMstrap (I), Polar TEAM² strap (II), Numetrex® Cardio-Shirt (III) and theshirt of the invention (IV). In Strong Physical Activity, due to thesweat, the amplitude of the signal is more similar between technologies,because the sweat helps the conduction of the electric potentials to theelectrode and decreases the impedance of the skin-electrode interface.

FIG. 11 shows RMS/Amplitude RS in mid-speed (H), fast-speed (I),torso-move (J), racket (K), jump (L), and all the activities, mid-speed,fast-speed, torso move, racket and jump (M) for Zephyr™ HxM strap (I),Polar TEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirt ofthe invention (IV). Again, we can see here that the shirt of theinvention has the best results.

FIG. 12 shows the percentage good QRS complex in strong physicalactivity for Zephyr™ HxM strap (I), Polar TEAM² strap (II), Numetrex®Cardio-Shirt (III) and the shirt of the invention (IV). The shirt of theinvention shows the best results.

FIG. 13 shows the autocorrelation value for Zephyr™ HxM strap (I), PolarTEAM² strap (II), Numetrex® Cardio-Shirt (III) and the shirt of theinvention (IV) in mid-speed (H), fast-speed (I), torso-move (J), racket(K) and jump (L). The shirt of the invention shows the best result.

In conclusion the shirt of the invention seems superior when we are in asituation of dry interface skin-electrode (no sweating), giving a muchbetter signal and more stable than the other systems. In a StrongPhysical situations, all the systems work better in terms of signalcapture thanks to the sweat, but the shirt of the invention is the onethat give a more signal recognizable morphology and stable signal andgives the best result in all of the situations and activities.

Comparative Example Between a Garment with the Sensor of the Inventionand the Garments with the Sensor of the Invention where the Orifices ofthe Electrode Area were not Filled with Silicone Rubber.

The shirt of the invention (IV), wherein the track and the electrode aremade of conductive fabric and the electrode area has the orifices filledwith silicone rubber, and the shirt of the invention without siliconerubber (V) were tried.

The protocol followed was the same described above. Significantdifferences were obtained in strong physical activity.

FIG. 14 shows RMS/Amplitude RS in mid-speed (H), fast-speed (I),torso-move (J), racket (K), jump (L), and all the activities, mid-speed,fast-speed, torso move, racket and jump (M) for the shirt of theinvention (IV) and the shirt of the invention without silicone rubber.The shirt of the invention has the best results, this means less noiseand better signal with silicone than without it. The results showed thebetter adherence to the skin.

Aspects of the present specification may also be described as follows:

1. A device comprising: an at least one sensor for acquiringphysiological signals, the at least one sensor comprising: a conductivelayer comprising a conductive fabric of interlaced conductive andnon-conductive fibers and a plurality of orifices throughout theconductive fabric, wherein the plurality of orifices are filled with asilicone rubber, and wherein the silicone rubber is attached to theconductive fabric without the use of an adhesive; and an electricalconnector connected to the conductive layer, the electrical connectorproviding a separable interface between the conductive layer and anelectronic instrument; and an electronic instrument for receiving andcollecting signals acquired from the at least one sensor.

2. The device according to embodiment 1, wherein the conductive layer ofthe at least one sensor comprises at least an electrode and a track, theelectrical connector being connected to the track.

3. The device according to embodiments 1-2, wherein the track of the atleast one sensor is covered with an insulating material.

4. The device according to embodiments 1-3, wherein the conductivefibers of the at least one sensor comprise 1) fibers including silver,copper, nickel, stainless steel, gold, silicone rubber loaded withcarbon or silver powder; 2) non-conductive fibers coated with aconductive material; or 3) a mixture thereof.

5. The device according to embodiments 1-4, wherein the non-conductivefibers of the at least one sensor comprise fibers including wool, silk,cotton, flax, jute, acrylic, polyamide polyester, nylon, or elasticyarn.

6. The device according to embodiments 1-5, wherein the conductivefibers of the at least one sensor comprise fibers made of silver coatednylon and the non-conductive fibers are made of nylon.

7. The device according to embodiments 1-6, wherein the silicone rubberof the at least one sensor is a silicone rubber with molecular weightcomprised between 400 g/mol and 600 g/mol.

8. The device according to embodiments 1-7, wherein the proportion ofthe conductive layer of the at least one sensor designed to be incontact with a skin surface comprises between 50% and 80% of theconductive layer and the proportion of the silicone rubber designed tobe in contact with the skin surface comprises between 20% and 50% of theconductive layer.

9. The device according to embodiments 1-8, wherein the electronicinstrument further stores and/or processes and/or transmits datareceived and collected from the at least one sensor.

10. The device according to embodiments 1-9, wherein the at least onesensor is coupled to the garment so as to be placed in contact with skinof a user during the use of the garment.

11. The device according to embodiments 1-10, wherein a portion of thegarment which is coupled to the sensor is designed for applying apressure equal or higher than 2 kPa.

12. The device according to embodiments 1-11, wherein the garmentcomprises two layers comprising an inner and an outer layer, and theouter layer is able to compress the sensor to a body of the user with apressure of at least 2 kPa.

13. The device according to embodiments 1-12, wherein the outer layercomprises a system to regulate the pressure.

14. A process for the preparation of an at least one sensor as definedin embodiments 1-13, the process comprising the steps of: a) die cuttingthe conductive fabric; b) adding a liquid silicone in a manner that theliquid silicone penetrates and fills the plurality of orifices presentin the conductive fabric; and c) curing the liquid silicone to form thesilicone rubber; wherein steps a) and b) can be carried out in anyorder.

15. The device according to embodiments 1-13, wherein the plurality oforifices of the at least one sensor form an organized pattern.

16. The device according to embodiments 1-13 and 15, wherein theorganized pattern is a circular pattern, sinusoidal pattern, straightline pattern, hexagon pattern, another pattern of geometric shapes, or acombination thereof.

17. The device according to embodiments 1-13 and 15-16, wherein thesilicone rubber of the at least one sensor is located only in theplurality of orifices.

18. The device according to embodiments 1-13 and 15-17, wherein the atleast one sensor is configured for detecting cardiac pulse, respiratoryfrequency, electrodermal response, electrical skin conductivity,electrocardiography, and/or electromyography.

In closing, regarding the exemplary embodiments of the present inventionas shown and described herein, it will be appreciated that sensors andassociated devices are disclosed and configured for acquiringphysiological signals. Because the principles of the invention may bepracticed in a number of configurations beyond those shown anddescribed, it is to be understood that the invention is not in any waylimited by the exemplary embodiments, but is generally directed tosensors and associated devices and is able to take numerous forms to doso without departing from the spirit and scope of the invention. It willalso be appreciated by those skilled in the art that the presentinvention is not limited to the particular geometries and materials ofconstruction disclosed, but may instead entail other functionallycomparable structures or materials, now known or later developed,without departing from the spirit and scope of the invention.

Certain embodiments of the present invention are described herein,including the best mode known to the inventor(s) for carrying out theinvention. Of course, variations on these described embodiments willbecome apparent to those of ordinary skill in the art upon reading theforegoing description. The inventor(s) expect skilled artisans to employsuch variations as appropriate, and the inventor(s) intend for thepresent invention to be practiced otherwise than specifically describedherein. Accordingly, this invention includes all modifications andequivalents of the subject matter recited in the claims appended heretoas permitted by applicable law. Moreover, any combination of theabove-described embodiments in all possible variations thereof isencompassed by the invention unless otherwise indicated herein orotherwise clearly contradicted by context.

Groupings of alternative embodiments, elements, or steps of the presentinvention are not to be construed as limitations. Each group member maybe referred to and claimed individually or in any combination with othergroup members disclosed herein. It is anticipated that one or moremembers of a group may be included in, or deleted from, a group forreasons of convenience and/or patentability. When any such inclusion ordeletion occurs, the specification is deemed to contain the group asmodified thus fulfilling the written description of all Markush groupsused in the appended claims.

Unless otherwise indicated, all numbers expressing a characteristic,item, quantity, parameter, property, term, and so forth used in thepresent specification and claims are to be understood as being modifiedin all instances by the term “about.” As used herein, the term “about”means that the characteristic, item, quantity, parameter, property, orterm so qualified encompasses a range of plus or minus ten percent aboveand below the value of the stated characteristic, item, quantity,parameter, property, or term. Accordingly, unless indicated to thecontrary, the numerical parameters set forth in the specification andattached claims are approximations that may vary. At the very least, andnot as an attempt to limit the application of the doctrine ofequivalents to the scope of the claims, each numerical indication shouldat least be construed in light of the number of reported significantdigits and by applying ordinary rounding techniques. Notwithstandingthat the numerical ranges and values setting forth the broad scope ofthe invention are approximations, the numerical ranges and values setforth in the specific examples are reported as precisely as possible.Any numerical range or value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements. Recitation of numerical ranges ofvalues herein is merely intended to serve as a shorthand method ofreferring individually to each separate numerical value falling withinthe range. Unless otherwise indicated herein, each individual value of anumerical range is incorporated into the present specification as if itwere individually recited herein.

Use of the terms “may” or “can” in reference to an embodiment or aspectof an embodiment also carries with it the alternative meaning of “maynot” or “cannot.” As such, if the present specification discloses thatan embodiment or an aspect of an embodiment may be or can be included aspart of the inventive subject matter, then the negative limitation orexclusionary proviso is also explicitly meant, meaning that anembodiment or an aspect of an embodiment may not be or cannot beincluded as part of the inventive subject matter. In a similar manner,use of the term “optionally” in reference to an embodiment or aspect ofan embodiment means that such embodiment or aspect of the embodiment maybe included as part of the inventive subject matter or may not beincluded as part of the inventive subject matter. Whether such anegative limitation or exclusionary proviso applies will be based onwhether the negative limitation or exclusionary proviso is recited inthe claimed subject matter.

The terms “a,” “an,” “the” and similar references used in the context ofdescribing the present invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. Further, ordinal indicators—such as “first,” “second,” “third,”etc.—for identified elements are used to distinguish between theelements, and do not indicate or imply a required or limited number ofsuch elements, and do not indicate a particular position or order ofsuch elements unless otherwise specifically stated. All methodsdescribed herein can be performed in any suitable order unless otherwiseindicated herein or otherwise clearly contradicted by context. The useof any and all examples, or exemplary language (e.g., “such as”)provided herein is intended merely to better illuminate the presentinvention and does not pose a limitation on the scope of the inventionotherwise claimed. No language in the present specification should beconstrued as indicating any non-claimed element essential to thepractice of the invention.

When used in the claims, whether as filed or added per amendment, theopen-ended transitional term “comprising” (along with equivalentopen-ended transitional phrases thereof such as “including,”“containing” and “having”) encompasses all the expressly recitedelements, limitations, steps and/or features alone or in combinationwith un-recited subject matter; the named elements, limitations and/orfeatures are essential, but other unnamed elements, limitations and/orfeatures may be added and still form a construct within the scope of theclaim. Specific embodiments disclosed herein may be further limited inthe claims using the closed-ended transitional phrases “consisting of”or “consisting essentially of” in lieu of or as an amendment for“comprising.” When used in the claims, whether as filed or added peramendment, the closed-ended transitional phrase “consisting of” excludesany element, limitation, step, or feature not expressly recited in theclaims. The closed-ended transitional phrase “consisting essentially of”limits the scope of a claim to the expressly recited elements,limitations, steps and/or features and any other elements, limitations,steps and/or features that do not materially affect the basic and novelcharacteristic(s) of the claimed subject matter. Thus, the meaning ofthe open-ended transitional phrase “comprising” is being defined asencompassing all the specifically recited elements, limitations, stepsand/or features as well as any optional, additional unspecified ones.The meaning of the closed-ended transitional phrase “consisting of” isbeing defined as only including those elements, limitations, stepsand/or features specifically recited in the claim, whereas the meaningof the closed-ended transitional phrase “consisting essentially of” isbeing defined as only including those elements, limitations, stepsand/or features specifically recited in the claim and those elements,limitations, steps and/or features that do not materially affect thebasic and novel characteristic(s) of the claimed subject matter.Therefore, the open-ended transitional phrase “comprising” (along withequivalent open-ended transitional phrases thereof) includes within itsmeaning, as a limiting case, claimed subject matter specified by theclosed-ended transitional phrases “consisting of” or “consistingessentially of.” As such, embodiments described herein or so claimedwith the phrase “comprising” are expressly or inherently unambiguouslydescribed, enabled and supported herein for the phrases “consistingessentially of” and “consisting of.”

All patents, patent publications, and other publications referenced andidentified in the present specification are individually and expresslyincorporated herein by reference in their entirety for the purpose ofdescribing and disclosing, for example, the compositions andmethodologies described in such publications that might be used inconnection with the present invention. These publications are providedsolely for their disclosure prior to the filing date of the presentapplication. Nothing in this regard should be construed as an admissionthat the inventors are not entitled to antedate such disclosure byvirtue of prior invention or for any other reason. All statements as tothe date or representation as to the contents of these documents isbased on the information available to the applicants and does notconstitute any admission as to the correctness of the dates or contentsof these documents.

While aspects of the invention have been described with reference to atleast one exemplary embodiment, it is to be clearly understood by thoseskilled in the art that the invention is not limited thereto. Rather,the scope of the invention is to be interpreted only in conjunction withthe appended claims and it is made clear, here, that the inventor(s)believe that the claimed subject matter is the invention.

What is claimed is:
 1. A garment comprising: an at least one sensor foracquiring physiological signals coupled to the garment so as to beplaced in contact with skin of a user during the use of the garment, theat least one sensor configured for transmitting said physiologicalsignals to an electronic instrument, and the at least one sensorcomprising: a conductive layer comprising: a conductive fabric ofinterlaced conductive and non-conductive fibers and a plurality oforifices throughout the conductive fabric, wherein the plurality oforifices are filled with a silicone rubber, and wherein the siliconerubber is attached to the conductive fabric without the use of anadhesive; an electrode; and a track; and an electrical connectorconnected to the track of the conductive layer, the electrical connectorproviding a separable interface between the conductive layer and theelectronic instrument.
 2. The garment of claim 1, wherein the track ofthe at least one sensor is covered with an insulating material.
 3. Thegarment of claim 1, wherein the conductive fibers of the at least onesensor comprise 1) fibers including silver, copper, nickel, stainlesssteel, gold, silicone rubber loaded with carbon or silver powder; 2)non-conductive fibers coated with a conductive material; or 3) a mixturethereof.
 4. The garment of claim 1, wherein the non-conductive fibers ofthe at least one sensor comprise fibers including wool, silk, cotton,flax, jute, acrylic, polyamide polyester, nylon, or elastic yarn.
 5. Thegarment of claim 1, wherein the conductive fibers of the at least onesensor comprise fibers made of silver coated nylon and thenon-conductive fibers are made of nylon.
 6. The garment of claim 1,wherein the silicone rubber of the at least one sensor is a siliconerubber with molecular weight comprised between 400 g/mol and 600 g/mol.7. The garment of claim 1, wherein the proportion of the conductivelayer of the at least one sensor designed to be in contact with a skinsurface comprises between 50% and 80% of the conductive layer and theproportion of the silicone rubber designed to be in contact with theskin surface comprises between 20% and 50% of the conductive layer. 8.The garment of claim 1, wherein a portion of the garment which iscoupled to the sensor is designed for applying a pressure equal orhigher than 2 kPa.
 9. The garment of claim 1, wherein the garmentcomprises two layers comprising an inner and an outer layer, and theouter layer is able to compress the sensor to a body of the user with apressure of at least 2 kPa.
 10. The garment of claim 9, wherein theouter layer comprises a system to regulate the pressure.
 11. The garmentof claim 1, wherein the plurality of orifices of the at least one sensorform an organized pattern.
 12. The garment of claim 11, wherein theorganized pattern is a circular pattern, sinusoidal pattern, straightline pattern, hexagon pattern, another pattern of geometric shapes, or acombination thereof.
 13. The garment of claim 1, wherein the siliconerubber of the at least one sensor is located only in the plurality oforifices.
 14. The garment of claim 1, wherein the at least one sensor isconfigured for detecting cardiac pulse, respiratory frequency,electrodermal response, electrical skin conductivity,electrocardiography, and/or electromyography.